Asthma is a common chronic condition affecting children and adults and is characterized by inflammation of the lower respiratory tract, cough, breathlessness, and recurrent episodes of polyphonic (musical) expiratory wheezing. The inherent defect in asthma is of airway smooth muscle or the inflammatory milieu which renders the lower airway smooth muscles hyper-reactive. Asthma exacerbation is defined as a sudden worsening of asthma symptoms that can last days to weeks. Patients with asthma are prone to acute exacerbations secondary to a variety of triggers, including viral or bacterial infections, pollens, smoke, aeroallergens, mold, chemicals, and fluctuations in air temperature. Although mortality from asthma is decreasing worldwide, it remains one of the most common causes of death in both children and adults, and morbidity remains a significant problem. Generally, deaths from asthma exacerbation occur prior to or shortly after patients are seen by emergency medical personnel suggesting that the timing of when asthmatics seek medical attention profoundly determines outcome.
Currently, there are no commercially available technologies to monitor and analyze breathing in asthma that could provide patients warning of impending respiratory failure. Commercially available peak flow meters provide snapshots of pulmonary function, but are quite unreliable. Patients and their families generally recognize they are “unwell”, and often initiate “sick” asthma care plans that include frequent inhalation of bronchodilator medicines, and occasionally initiation of enteral steroid therapy. Generally, these patients will contact their primary care physician in the acute phase, and seek advice as to whether and when they should be seen in the office, clinic, or emergency room. Commonly, patients receiving “sick” asthma care plan management improve at home and are not seen during the acute illness by a physician. However, it is not uncommon that patients who remain at home and who self-administer frequently inhaled bronchodilator therapy (more frequently than every 2-3 hours) for prolonged periods of time (>24 hours) abruptly (within minutes to hours) worsen prompting calls to 911 for emergency services in the home. A small percentage of these patients require resuscitation and die in the home or prior to arrival in the emergency room. An early warning signal instructing asthma patients to seek medical attention for advancing respiratory distress prior to them becoming critically ill would be of monumental importance in preventing asthma morbidity and mortality. In addition, detecting and treating asthma attacks early have important therapeutic value in that each asthma attack makes the underlying disease worse. Thus, a major challenge in pulmonary medicine is to design a technology enabling outpatient monitoring of asthma severity in real time. In addition to asthma, this technology is useful in diagnosing the progression of Chronic Obstructive Pulmonary Disease (“COPD”), which includes chronic bronchitis and emphysema.
Anaphylaxis, according to another example, is a severe and potentially life threatening allergic reaction to foods, insect venom, medications, and other allergens. The symptoms of anaphylaxis are numerous, complex and confusing. Many people do not recognize the early symptoms, including teachers and child caregivers, or choose to downplay or ignore the danger out of fear or denial. Denial is a common coping mechanism for stress, and may cause a person to delay or fail to react to the situation. Time is critical when experiencing anaphylaxis.
The only treatment for anaphylaxis is the injection of epinephrine. One in 50 Americans are at risk of experiencing anaphylaxis in their lifetime, with estimates of 500-1000 people dying from anaphylaxis every year.
After contact with an allergen, a person can have as little as 10 minutes (bee sting) to 30 minutes (food allergy) until cardiac arrest and death. Chances of survival increase the sooner they receive a dose of epinephrine, commonly applied using an EpiPen®, which can reverse life-threatening airway constriction. This is an especially difficult problem in children and their parents, and in many situations lives have been lost because epi-pens aren't available, can't be found, or have expired, or the sufferer has simply lost consciousness before they can inject themselves. Additionally, allergy testing is performed in physicians' offices by providing a small amount of allergen to the patient and asking the patient how they feel. There is no objective measure to provide the physician to either gauge the degree of allergic response or even its presence. Patients allergic to foods and drugs, such as penicillin and chemotherapy drugs, are treated by desensitizing them, giving the patients small amounts of allergen in increasing doses. Again, the only feedback to the physician is to ask the patient if they feel an allergic response. Thus, lives could be saved if it were possible to detect the early onset of anaphylaxis, and to initiate treatment automatically.
Accordingly, present embodiments are directed to solving the above and other needs, including providing technological components combined and configured into various different device embodiments for the treatment of acute conditions, such as anaphylaxis and asthma, as described herein.